NCT00133952

Brief Summary

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_3

Geographic Reach
10 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

January 28, 2016

Completed
Last Updated

October 6, 2016

Status Verified

August 1, 2016

Enrollment Period

5.9 years

First QC Date

August 22, 2005

Results QC Date

December 22, 2015

Last Update Submit

August 25, 2016

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48

    SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).

    Baseline through 48 months

Secondary Outcomes (8)

  • Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula

    Baseline, 24 months

  • Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24

    Baseline through 24 months

  • Time to Focal Photocoagulation

    Baseline through 48 months

  • Change From Baseline to Month 24 in Contrast Sensitivity

    Baseline, 24 months

  • Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula

    Baseline, up to 24 months

  • +3 more secondary outcomes

Study Arms (2)

Ruboxistaurin

EXPERIMENTAL

32 mg taken orally daily for up to 48 months

Drug: Ruboxistaurin

Placebo

PLACEBO COMPARATOR

Taken orally daily for up to 48 months

Drug: Placebo

Interventions

RuboxistaurinDRUG

Administered orally

Also known as: LY333531
Ruboxistaurin
PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or 2 diabetes
  • years or older
  • Hemoglobin A1c (HbA1c) less than or equal to 11%
  • Mild to very severe non-proliferative diabetic retinopathy in the study eye
  • Clinically significant macular edema in the study eye not within 100 microns of center of macula

You may not qualify if:

  • Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
  • Glaucoma in the study eye
  • Unstable cardiovascular disease
  • Major surgery within past 3 months
  • Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Phoenix, Arizona, 85020, United States

Location

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Artesia, California, 90701, United States

Location

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Newark, Delaware, 19713, United States

Location

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Jacksonville, Florida, 32204, United States

Location

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Augusta, Georgia, 30909, United States

Location

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Indianapolis, Indiana, 46280, United States

Location

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Baltimore, Maryland, 21287, United States

Location

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Boston, Massachusetts, 02215, United States

Location

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Grand Rapids, Michigan, 49525, United States

Location

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Portsmouth, New Hampshire, 03801, United States

Location

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Slingerlands, New York, 12159, United States

Location

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Asheville, North Carolina, 28803, United States

Location

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Lakewood, Ohio, 44107, United States

Location

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Kingston, Pennsylvania, 18704, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

Location

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West Mifflin, Pennsylvania, 15122, United States

Location

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Dallas, Texas, 75231, United States

Location

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Houston, Texas, 77030, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Halifax, Nova Scotia, B3H 2Y9, Canada

Location

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London, Ontario, N6A 4G5, Canada

Location

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Mississauga, Ontario, L4W 1W0, Canada

Location

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Aarhus, 8000, Denmark

Location

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Glostrup Municipality, 2600, Denmark

Location

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Bonn, 53127, Germany

Location

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Leipzig, 04103, Germany

Location

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Münster, 48145, Germany

Location

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Ulm, 89075, Germany

Location

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Kaunas, LT-50009, Lithuania

Location

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Mexico City, 6700, Mexico

Location

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Monterrey, 64710, Mexico

Location

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San Luis Potosí City, 78395, Mexico

Location

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Coimbra, 3000-548, Portugal

Location

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Lisbon, 1150-199, Portugal

Location

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Porto, 4202-451, Portugal

Location

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Bucharest, 050098, Romania

Location

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Alicante, 03016, Spain

Location

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Barcelona, 08022, Spain

Location

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Valladolid, 47071, Spain

Location

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London, Greater London, SE5 9RS, United Kingdom

Location

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London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

  • Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

    PMID: 23404115DERIVED

Related Links

MeSH Terms

Interventions

ruboxistaurin

Results Point of Contact

Title
info@chroma-derm.com
Organization
Chromaderm
info@chroma-derm.com

Study Officials

  • Karl Beutner

    Chromaderm, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 6, 2016

Results First Posted

January 28, 2016

Record last verified: 2016-08

Locations

LI(1)ES(3)GB(2)PT(3)DE(4)DK(2)ME(3)RO(1)CA(3)US(19)